MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number EVO-FC-R-20-25-10-E

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.

Event Description

Mdr- (b)(4) - device issues: stent migration, relationship: device; not related, procedure; not related, pre-existing; no, deficiency: no.Distal stent migration to jejunum- sepsis - anastomotic abscess - medical intervention - placement of eso-sponge and continuous aspiration with probe.Patient outcome: resolved ( patient recovered / stabilized), treatment: medical: eso-sponge and continuous aspiration with probe, death: no.

Event Description

A supplemental report is being submitted due to completion of the investigation on the 26-oct-2023.

Manufacturer Narrative

Device evaluation: off label use complaints are considered to be unforeseen misuse.It is unknown how the device will function outside of its intended use.Trending will monitor if any future investigation is required.The evo-fc-r-20-25-10-e device of lot number c1751202 could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to a pmcf study ¿mdr- 2054 301-034 ae3 - device issues: stent migration¿ manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records of lot number c1751202 did not reveal any discrepancies that could have contributed to this complaint issue.Instructions for use and/label review: the instructions for use, ifu0067 which accompanies this device, states ¿¿ this device is used to maintain luminal patency of the esophagus in cases of; obstruction cause by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas¿¿ and ¿¿additional adverse events include, but are not limited to: airway compression, allergic reaction to nickel, aortoesophageal fistula and arterioesophageal fistula , chest or retrosternal pain, death( other than due to normal disease progression.Dysphagia,edema, erosion or perforation of stent into adjacent vascular structures , esophageal ulceration and erosion, esophagitis, fistula involving trachea, bronchi or pleural space, food bolus impaction , foreign body sensation or reaction, gas bloat , inadequate stent expansion, intestinal obstruction secondary to migration , mediastinitis or peritonitis , nausea, pain/discomfort, reclusion, sensitivity to metal components, sepsis, stent misplacement and/or migration, tracheal obstruction , tumour over growth and wire entrapment.¿¿ there is evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.The instruction for use advises that the intended use ¿¿ this device is used to maintain luminal patency of the esophagus in cases of; obstruction cause by intrinsic or extrinsic malignancies, refractory benign strictures, or to seal tracheoesophageal fistulas.¿¿ it is known from the available information that the stent was used in the treatment of a esophageal jejunal anastomosis dehiscence.It is likely the off-label use of the stent would have contributed to the migration of the stent, and it is known from the available that the sepsis reported was caused by an anastomotic abscess.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the pmcf study the stent migrated to the jejunum 18 days post stent placement.Confirmed quantity of (b)(4) device, confirmed used.According to the pmcf study, the anastomotic abscess was treated with placement of eso-sponge and continuous aspiration with probe.The patient did not experience any adverse effects due to this occurrence.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the ifu with respect to the intended use of the device.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16830474
• MDR Text Key: 314159178
• Report Number: 3001845648-2023-00274
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551715
• UDI-Public: (01)10827002551715(17)220812(10)C1751202
• Combination Product (y/n): N
• PMA/PMN Number: K093619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Catalogue Number: EVO-FC-R-20-25-10-E
• Device Lot Number: C1751202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 89 KG